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Folic acid is indicated for the treatment of-

• Folic acid deficiency
• Megaloblastic anemia
• Anemias of nutritional origins, pregnancy, infancy, or childhood.

Drugs for Megaloblastic Anemia, Vitamin-B preparations

Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase.

Adults-

• Initially: 5 mg daily for 4 months.
• maintenance: 5 mg every 1-7 days depending on the underlying disease.

Children-

• Up to 1 year: 500 mcg/kg daily.
• Over 1 year: Same as adult dose.

Folic acid is generally well tolerated. Gastro-intestinal disturbances may occur. Hypersensitivity reactions have been reported rarely.

Folic acid is contraindicated in patients who have shown previous intolerance to the drug.

It should be used with caution in patients who may have folate dependent tumours. It should never be given alone or in conjunction with inadequate amounts of vitamin B12 for the treatment of undiagnosed megaloblastic anaemia. Although folic acid may produce a haematopoietic response in patients with a megaloblastic anaemia due to vitamin B12 deficiency it should not be given alone in vitamin B12 deficiency states as it may precipitate the onset of subacute combined degeneration of the cord. In elderly people a cobalamin absorption test should be done before long term folate. No harmful results found from short courses of folate.

None has been reported.

No special precautions are known.

Store below 30°C in a dry place, away from light. Keep out of the reach of children.

Calcium Folinate is indicated in:

• To diminish the toxicity and counteract the effect of impaired Methotrexate elimination.
• To treat the Megaloblastic anemia due to folate deficiency, as in sprue, nutritional deficiency.
• To treat the Megaloblastic anemia of pregnancy and infancy.

Supportive Care Therapy

Calcium Folinate is a Calcium salt of Folinic acid (citrovorum factor), is a mixture of the diastereoisomers of the 5-formyl derivative of Tetrahydrofolic acid. It is a metabolite of Folic acid and an essential co-enzyme for nucleic acid synthesis used in cytotoxic therapy.

Oral-

• Reduction of harmful effects of folic acid antagonists: The dose is usually one 5-15 mg tablet every 6 hours for 2 to 3 days.
• Megaloblastic anemia: In the treatment of Megaloblastic anemia, the dose is one 5-15 mg tablet daily.

Intravenous-

• Advanced Colorectal Cancer: Folinic Acid is administered at 200 mg/m² by slow intravenous injection followed by 5-fluorouracil at 370 mg/m² by intravenous injection. Or 20 mg/m  2 by slow intravenous injection followed by 5-fluorouracil at 425 mg/m² by intravenous injection. Treatment is repeated daily for 5 days. This 5 day treatment course may be repeated at 4 weeks interval, for 2 courses and then may repeated at 4-5 weekly intervals if the patient has recovered completely from the toxic effects of the prior treatment course.
• Folinic acid rescue after high dose Methotrexate Therapy: Calcium Folinate starts 24 hours after the beginning of the methotrexate infusion at dose of 15mg (10 mg/m² ) every 6 hours for 10 doses.

Intramuscular-

• Folate deficient megaloboastic anaemia: Up to 1 mg/day. Or, as directed by the registered physician.

Calcium Folinate therapy is contraindicated for the following:

• Known hypersensitivity to Calcium Folinate, or to any components of the product formulation.
• Pernicious anemia or other Megaloblastic anemia where Vitamin B₁₂ is deficient.

Calcium Folinate treatment may mask pernicious anemia and other Megaloblastic anemia resulting from Vitamin B12 deficiency.

Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Many cytotoxic medicinal products- direct or indirect DNA synthesis inhibitors- lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with Folinic acid.

In epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.

There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcium Folinate is administered to a nursing mother.

There have been no reported sequelae in patients who have received significantly more Calcium Folinate than the recommended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of folic acid antagonists.

Do not store above 30°C. Keep away from light and out of the reach of children.

Calcium Folinate is indicated in:

• To diminish the toxicity and counteract the effect of impaired Methotrexate elimination.
• To treat the Megaloblastic anemia due to folate deficiency, as in sprue, nutritional deficiency.
• To treat the Megaloblastic anemia of pregnancy and infancy.

Supportive Care Therapy

Calcium Folinate is a Calcium salt of Folinic acid (citrovorum factor), is a mixture of the diastereoisomers of the 5-formyl derivative of Tetrahydrofolic acid. It is a metabolite of Folic acid and an essential co-enzyme for nucleic acid synthesis used in cytotoxic therapy.

Oral-

• Reduction of harmful effects of folic acid antagonists: The dose is usually one 5-15 mg tablet every 6 hours for 2 to 3 days.
• Megaloblastic anemia: In the treatment of Megaloblastic anemia, the dose is one 5-15 mg tablet daily.

Intravenous-

• Advanced Colorectal Cancer: Folinic Acid is administered at 200 mg/m² by slow intravenous injection followed by 5-fluorouracil at 370 mg/m² by intravenous injection. Or 20 mg/m  2 by slow intravenous injection followed by 5-fluorouracil at 425 mg/m² by intravenous injection. Treatment is repeated daily for 5 days. This 5 day treatment course may be repeated at 4 weeks interval, for 2 courses and then may repeated at 4-5 weekly intervals if the patient has recovered completely from the toxic effects of the prior treatment course.
• Folinic acid rescue after high dose Methotrexate Therapy: Calcium Folinate starts 24 hours after the beginning of the methotrexate infusion at dose of 15mg (10 mg/m² ) every 6 hours for 10 doses.

Intramuscular-

• Folate deficient megaloboastic anaemia: Up to 1 mg/day. Or, as directed by the registered physician.

Calcium Folinate therapy is contraindicated for the following:

• Known hypersensitivity to Calcium Folinate, or to any components of the product formulation.
• Pernicious anemia or other Megaloblastic anemia where Vitamin B₁₂ is deficient.

Calcium Folinate treatment may mask pernicious anemia and other Megaloblastic anemia resulting from Vitamin B12 deficiency.

Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Many cytotoxic medicinal products- direct or indirect DNA synthesis inhibitors- lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with Folinic acid.

In epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.

There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcium Folinate is administered to a nursing mother.

There have been no reported sequelae in patients who have received significantly more Calcium Folinate than the recommended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of folic acid antagonists.

Do not store above 30°C. Keep away from light and out of the reach of children.

This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

Drugs for Infertility, Trophic Hormones & Related Synthetic Drugs

FSH is a product containing a highly purified preparation of human follicle stimulating hormone (FSH-HP) extracted from the urine of postmenopausal women. Third generation of urinary gonadotrophins FSH-HP;Use of monoclonal antibodies specific to FSH resulted in further refinements in manufacture, and the production of highly purified (HP) urinary FSH. The presence of LH is less than 0.1% per 75 IU of FSH & Unidentified urinary proteins are less than 5% in Human FSH-HP. FSH consists of two non-covalently linked glycoproteins designated as the alfa and beta subunits. The alfa subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The beta subunit has 111 amino acids of which two are modified by attachment of carbohydrates. FSH is a sterile, lyophilized powder intended for subcutaneous (SC) or intramuscular (IM) injection after reconstitution with sterile 0.9% Sodium Chloride Injection. Each vial of FSH contains 75 International Units (IU) of Follicle Stimulating Hormone (FSH) which is reconstituted with diluents. The in vivo biological activity of Urofollitropin (FSH) for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle- stimulating hormone (FSH, Urofollitropin), Urinary, and Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995. FSH is a glycoprotein that is acidic and water-soluble.

There are great inter-and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasonography and monitoring of oestradiol levels. There should be consideration to minimize the risk of unwanted ovarian hyperstimulation. FSH can be given either alone, or in combination with a GnRH analogue to prevent premature luteinisation. In the latter case, especially when using a GnRH agonist, a higher total treatment dose of FSH may be required to achieve an adequate follicular response. Clinical experience with FSH is based on up to three treatment cycles in both indications. Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.

Ovulation Induction in Women: Starting daily dose of 50 international units (IU) of FSH is administered subcutaneously or intramuscularly for at least the first 7 days. The dose is increased by 25 or 50 international units (IU) at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response. When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5000 to 10,000 international units (IU) of human chorionic gonadotropin (HCG). The woman and her partner should have intercourse daily, beginning on the day prior to the administration of HCG and until ovulation becomes apparent

Assisted Reproductive Technology (ART): In Women; Starting dose of 150 to 225 international units (IU) of FSH is administered intramuscularly for at least the first 4 days of treatment. Subsequent doses are adjusted based upon ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Final oocyte maturation is induced with a dose of 5000-10,000 international units of HCG Oocyte (egg) retrieval is performed 34 to 36 hours later

Polycystic Ovarian Hyperstimulation (PCOS): FSH injections are therefore given each morning as an intramuscular injection. It is best to start with the lowest dose of FSH per day (using 50 IU per day). These doses are used for 4 to 6 days at a time. The ovarian response is determined by measuring oestrogen levels in the blood. When the oestrogen begins to rise, the FSH is successfully growing an egg or eggs. If there is no response to a dose of FSH in 5- 6 days of injections the dose will be increased. The normal dose increments are 75 units, 112 units, 150 units and 225 units per day. Most patients respond with 75 to 150 IU per day. However it is very important that increments are only made cautiously.

Dosage in Male: Induction of Spermatogenesis in Men Pre-treatment with HCG alone (1500 international units (IU) twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of HCG treatment, the dose may be increased to 3000 international units (IU) twice a week. After normalization of serum testosterone levels, administer 450 international units (IU) per week (225 international units twice weekly or 150 international units (IU) three times weekly) of FSH subcutaneously with the same pre-treatment HCG dose used to normalize testosterone level.

To prevent painful injections and minimize leakage from the injection site FSH should be slowly administered intramuscularly or subcutaneously. The subcutaneous injection site should be alternated to prevent lipoathrophy. Any unused solution should be discarded. Subcutaneous injection of FSH may be carried out by patient or partner, provided that proper instructions are given by the physician. Self administration of FSH should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.

FSH sometimes excites the ovaries too much. This may cause pelvic pain or breathing problems. It may also make you urinate less. In rare cases, patients with this problem have had serious lung problems, including fluid in the lungs, troublebreathing, and worsening of asthma blood clots and strokes, severe pelvic pain, chest pain, or abdominal pain, Nausea, Vomiting, Sudden weight gain, Bloating, Trouble, breathing. FSH may cause twins or multiple births. The most common side effects with FSH are headache, vaginal bleeding, nausea, and hot flashes. Sometimes there is a reaction at the spot where you give yourself the injection. This can include bruising, pain, or redness.

The presence of uncontrolled non gonodalendocrinopathies (e.g. thyroid, adrenal or pituitary disorders) should be excluded

• In pregnancies occurring after induction of ovulation with gonadotrophin preparations, there is an increased risk of multiple gestations (Multiple birth)
• There has been no reports of hypersensitivity to FSH, but there remains the possibility of anaphylactic responses
• The first injection of FSH should be performed under direct medical supervision
• Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
• Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population.
• Unwanted ovarian hyperstimulation in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment. Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values. The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of controlled
• ovarian hyperstimulation in medically assisted reproduction programs), the administration of FSH should be discontinued. In that case pregnancy should be avoided and HCG must be withheld, because it may induce, in addition to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS).
• In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response

No drug/drug interaction studies have been conducted for Urofollitropin in humans

Pregnancy Category X. FSH must not be used during pregnancy and lactation.

No data on acute toxicity of FSH in humans is available, but the acute toxicity of FSH and of urinary gonadotrophin preparations in animal studies has been shown to be very low. Too high a dosage of FSH may lead to hyperstimulation of the ovaries.

To prepare the solution, inject 1 ml of sterile saline for injection into the vial of 75 IU FSH. Do not shake, but gently swirl until the solution is clear. Generally FSH dissolves immediately. Check the liquid in the container; if it is not clear or contains particles, do not use it. For patients requiring a single injection from multiple vials of FSH up to 4 vials can be reconstituted with 1 ml of sterile saline for injection. This can be accomplished by reconstituting a single vial as described above. Then draw the entire contents of the first vial into a syringe and inject the contents into a second vial of lyophilized Urofollitropin. Gently swirl the second vial, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 2 additional vials for a total up to 4 vials (300 IU) of 75 IU FSH.

Store at 2°C to 8°C (in a refrigerator). Do not keep in deep freeze. Can be stored below 25°C for a maximum of 3 months. Protect from light & keep in dry place .

This tablet is indicated for the treatment and prophylaxis of Folic Acid and Zinc deficiencies.

Specific mineral & vitamin combined preparations

This tablet is a special preparation of Folic Acid & Zinc Sulfate Monohydrate. Zinc is an essential trace element required for human nutrition and involved in a number of body enzyme system. Severe Zinc deficiency causes skin lesion, alopecia, diarrhoea, increased susceptibility of infections, cognitive impairment, etc. Folic Acid is a member of the B-Vitamins group. It is reduced in the body to tetrahydrofolate, which is the coenzyme for various metabolic processes including the synthesis of purine and pyrimidine nucleotides, and hence the synthesis of DNA. It is also involved in some amino acid conversions. Deficiency of Folic Acid may cause megaloblastic anaemia, develops when the dietary intake is inadequate, as in malnutrition, from malabsorption, from increased utilization as in pregnancy of conditions such as haemolytic anaemia, and as a result of administration of folate antagonists.

Orally 1 tablet daily or as directed by the physician.

Folic Acid & Zinc is well tolerated in the recommended dose. Occasionally gastrointestinal disturbances like abdominal pain, dyspepsia, nausea, vomiting, fever and respiratory distress may occur.

Zinc is contraindicated in patients having hypersensitivity to Zinc. Folic Acid is contraindicated in untreated cobalamine deficiency

A large amount of Calcium decreases the absorption of Zinc. In case of Folic Acid, no drug interactions have been reported.

Recommended during pregnancy & lactation.

Zinc Sulfate is corrosive in overdose. Symptoms are corrosion and inflammation of the mucous membrane of the mouth and stomach.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Folic acid is indicated for the treatment of-

• Folic acid deficiency
• Megaloblastic anemia
• Anemias of nutritional origins, pregnancy, infancy, or childhood.

Drugs for Megaloblastic Anemia, Vitamin-B preparations

Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase.

Adults-

• Initially: 5 mg daily for 4 months.
• maintenance: 5 mg every 1-7 days depending on the underlying disease.

Children-

• Up to 1 year: 500 mcg/kg daily.
• Over 1 year: Same as adult dose.

Folic acid is generally well tolerated. Gastro-intestinal disturbances may occur. Hypersensitivity reactions have been reported rarely.

Folic acid is contraindicated in patients who have shown previous intolerance to the drug.

It should be used with caution in patients who may have folate dependent tumours. It should never be given alone or in conjunction with inadequate amounts of vitamin B12 for the treatment of undiagnosed megaloblastic anaemia. Although folic acid may produce a haematopoietic response in patients with a megaloblastic anaemia due to vitamin B12 deficiency it should not be given alone in vitamin B12 deficiency states as it may precipitate the onset of subacute combined degeneration of the cord. In elderly people a cobalamin absorption test should be done before long term folate. No harmful results found from short courses of folate.

None has been reported.

No special precautions are known.

Store below 30°C in a dry place, away from light. Keep out of the reach of children.

This is indicated for the treatment and prophylaxis of Iron, Folic acid, Vitamin B complex and Vitamin C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy.

Iron & Vitamin Combined preparations

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

Recommended adult dose is one capsule daily. In more severe deficiency states, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Iron therapy is contraindicated in haemachromatosis and haemosiderosis, and in patients receiving repeated blood transfusion or with anaemia not due to by iron deficiency. It should be given cautiously to patients taking Levodopa as one of the ingredients (Pyridoxine) reduces the effect of Levodopa.

Care should be taken in patients who may develop iron overload, such as those with hemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Care should be taken when given to patients with Iron storage or Iron absorption disease. Iron form chelates with antacids and Tetracycline and absorption of all these may be impaired if taken concurrently

It is recommended during pregnancy and lactation.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children fewer than 6. Avoid higher doses if you have liver disease or hemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours. Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No cases of Folic acid overdosages have been reported. Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Store in a dry place below 25° C. Protect from light.

This is indicated for the treatment and prophylaxis of Zinc, Iron, Folic Acid, B-vitamins and Vitamin-C deficiency especially during pregnancy and lactation.

Iron & Vitamin Combined preparations

Zinc sulfate precipitates protein and this is responsible for the astringent and weak antiseptic activity of Zn sulfate. It also produces mild vasodilation. Zinc sulfate can also be used orally or systemically as a zinc supplement. 220 mg of zinc sulfate (heptahydrate) contains 50 mg of elemental zinc.

Iron is an essential mineral, with several important roles in the body. For example, it helps to make red blood cells, which carry oxygen around the body. A lack of iron can lead to iron deficiency anaemia. Liver is a good source of iron, don't eat it if you are pregnant. This is because it is also rich in vitamin A which, in large amounts, can harm your unborn baby.

Folic acid is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoesis. It also promotes WBC and platelet production in folate-deficiency anaemia.

Nicotinamide is a vitamin B3 derivative. It is incorporated into coenzymes nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP), which are involved in multiple cellular metabolic pathways.

Vitamin C is necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid.

Vitamin B complex: The building blocks for good health come from a variety of foods, even if they are from the same family of nutrients. Such is the case with vitamin B, a key player in maintaining cell health and keeping you energized.

Not all types of vitamin B do the same thing. Additionally, the different types of vitamin B all come from different types of foods.

Vitamin B deficiencies can lead to health problems. Sometimes a doctor will prescribe a supplement when they think you’re not getting enough.

One capsule daily. In more severe cases, 2 capsules a day may be required or as directed by the physician.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Iron chelates with tetracycline and absorption may be impaired.

Recommended.

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children below 6 years. Avoid higher doses if you have liver disease or haemochromatosis; excess can cause bloody diarrhea, vomiting, acidosis, darkened stools, abdominal pain. Symptoms may clear in a few hours.

Riboflavin is reported to be completely safe and no toxic symptoms have been reported so far. Higher doses of Nicotinamide may cause vomiting, diarrhea. Sensory neuropathy was observed in individuals consuming more than 200 mg Pyridoxine for very long periods. No case of Folic acid overdodage has been reported.

Acute ingestion of Ascorbic acid, even of massive doses, is unlikely to cause significant effects.

Zinc toxicity has been seen in both acute and chronic forms. Ingestion of 150 to 450 mg of zinc per day have been associated with low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins. So, Zinc at its RDA dosages dose not cause any significant effect.

Store in a dry place below 25 °C. Protect from light.

Calcium Folinate is indicated in:

• To diminish the toxicity and counteract the effect of impaired Methotrexate elimination.
• To treat the Megaloblastic anemia due to folate deficiency, as in sprue, nutritional deficiency.
• To treat the Megaloblastic anemia of pregnancy and infancy.

Supportive Care Therapy

Calcium Folinate is a Calcium salt of Folinic acid (citrovorum factor), is a mixture of the diastereoisomers of the 5-formyl derivative of Tetrahydrofolic acid. It is a metabolite of Folic acid and an essential co-enzyme for nucleic acid synthesis used in cytotoxic therapy.

Oral-

• Reduction of harmful effects of folic acid antagonists: The dose is usually one 5-15 mg tablet every 6 hours for 2 to 3 days.
• Megaloblastic anemia: In the treatment of Megaloblastic anemia, the dose is one 5-15 mg tablet daily.

Intravenous-

• Advanced Colorectal Cancer: Folinic Acid is administered at 200 mg/m² by slow intravenous injection followed by 5-fluorouracil at 370 mg/m² by intravenous injection. Or 20 mg/m  2 by slow intravenous injection followed by 5-fluorouracil at 425 mg/m² by intravenous injection. Treatment is repeated daily for 5 days. This 5 day treatment course may be repeated at 4 weeks interval, for 2 courses and then may repeated at 4-5 weekly intervals if the patient has recovered completely from the toxic effects of the prior treatment course.
• Folinic acid rescue after high dose Methotrexate Therapy: Calcium Folinate starts 24 hours after the beginning of the methotrexate infusion at dose of 15mg (10 mg/m² ) every 6 hours for 10 doses.

Intramuscular-

• Folate deficient megaloboastic anaemia: Up to 1 mg/day. Or, as directed by the registered physician.

Calcium Folinate therapy is contraindicated for the following:

• Known hypersensitivity to Calcium Folinate, or to any components of the product formulation.
• Pernicious anemia or other Megaloblastic anemia where Vitamin B₁₂ is deficient.

Calcium Folinate treatment may mask pernicious anemia and other Megaloblastic anemia resulting from Vitamin B12 deficiency.

Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Many cytotoxic medicinal products- direct or indirect DNA synthesis inhibitors- lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with Folinic acid.

In epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.

There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcium Folinate is administered to a nursing mother.

There have been no reported sequelae in patients who have received significantly more Calcium Folinate than the recommended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of folic acid antagonists.

Do not store above 30°C. Keep away from light and out of the reach of children.

Calcium Folinate is indicated in:

• To diminish the toxicity and counteract the effect of impaired Methotrexate elimination.
• To treat the Megaloblastic anemia due to folate deficiency, as in sprue, nutritional deficiency.
• To treat the Megaloblastic anemia of pregnancy and infancy.

Supportive Care Therapy

Calcium Folinate is a Calcium salt of Folinic acid (citrovorum factor), is a mixture of the diastereoisomers of the 5-formyl derivative of Tetrahydrofolic acid. It is a metabolite of Folic acid and an essential co-enzyme for nucleic acid synthesis used in cytotoxic therapy.

Oral-

• Reduction of harmful effects of folic acid antagonists: The dose is usually one 5-15 mg tablet every 6 hours for 2 to 3 days.
• Megaloblastic anemia: In the treatment of Megaloblastic anemia, the dose is one 5-15 mg tablet daily.

Intravenous-

• Advanced Colorectal Cancer: Folinic Acid is administered at 200 mg/m² by slow intravenous injection followed by 5-fluorouracil at 370 mg/m² by intravenous injection. Or 20 mg/m  2 by slow intravenous injection followed by 5-fluorouracil at 425 mg/m² by intravenous injection. Treatment is repeated daily for 5 days. This 5 day treatment course may be repeated at 4 weeks interval, for 2 courses and then may repeated at 4-5 weekly intervals if the patient has recovered completely from the toxic effects of the prior treatment course.
• Folinic acid rescue after high dose Methotrexate Therapy: Calcium Folinate starts 24 hours after the beginning of the methotrexate infusion at dose of 15mg (10 mg/m² ) every 6 hours for 10 doses.

Intramuscular-

• Folate deficient megaloboastic anaemia: Up to 1 mg/day. Or, as directed by the registered physician.

Calcium Folinate therapy is contraindicated for the following:

• Known hypersensitivity to Calcium Folinate, or to any components of the product formulation.
• Pernicious anemia or other Megaloblastic anemia where Vitamin B₁₂ is deficient.

Calcium Folinate treatment may mask pernicious anemia and other Megaloblastic anemia resulting from Vitamin B12 deficiency.

Calcium Folinate should only be used with 5-fluorouracil or Methotrexate under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.

Many cytotoxic medicinal products- direct or indirect DNA synthesis inhibitors- lead to macrocytosis (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Such macrocytosis should not be treated with Folinic acid.

In epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides, there is a risk to increase the frequency of seizures due to a decrease of plasma concentrations of anti-epileptic drug.

There are no adequate and well-controlled clinical studies conducted in pregnant or breastfeeding women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcium Folinate is administered to a nursing mother.

There have been no reported sequelae in patients who have received significantly more Calcium Folinate than the recommended dosage. However, excessive amounts of Calcium Folinate may nullify the chemotherapeutic effect of folic acid antagonists.

Do not store above 30°C. Keep away from light and out of the reach of children.

This tablet is indicated for the treatment and prophylaxis of Folic Acid and Zinc deficiencies.

Specific mineral & vitamin combined preparations

This tablet is a special preparation of Folic Acid & Zinc Sulfate Monohydrate. Zinc is an essential trace element required for human nutrition and involved in a number of body enzyme system. Severe Zinc deficiency causes skin lesion, alopecia, diarrhoea, increased susceptibility of infections, cognitive impairment, etc. Folic Acid is a member of the B-Vitamins group. It is reduced in the body to tetrahydrofolate, which is the coenzyme for various metabolic processes including the synthesis of purine and pyrimidine nucleotides, and hence the synthesis of DNA. It is also involved in some amino acid conversions. Deficiency of Folic Acid may cause megaloblastic anaemia, develops when the dietary intake is inadequate, as in malnutrition, from malabsorption, from increased utilization as in pregnancy of conditions such as haemolytic anaemia, and as a result of administration of folate antagonists.

Orally 1 tablet daily or as directed by the physician.

Folic Acid & Zinc is well tolerated in the recommended dose. Occasionally gastrointestinal disturbances like abdominal pain, dyspepsia, nausea, vomiting, fever and respiratory distress may occur.

Zinc is contraindicated in patients having hypersensitivity to Zinc. Folic Acid is contraindicated in untreated cobalamine deficiency

A large amount of Calcium decreases the absorption of Zinc. In case of Folic Acid, no drug interactions have been reported.

Recommended during pregnancy & lactation.

Zinc Sulfate is corrosive in overdose. Symptoms are corrosion and inflammation of the mucous membrane of the mouth and stomach.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.

Adult: One Capsule daily before food or as directed by the physician.

Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.

It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.

Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.

Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.

Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.

Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.

Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.

Ophthalmic antibacterial drugs

The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Eye Drops: One drop in the affected eye 3 times per day for 7 days.

Eye Ointment: It should be applied thinly and evenly to the affected eye three times a day for the first two days and for the next five days apply two times a day or as advised by the registered physician.

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

Moxifloxacin Hydrochloride ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones, or to any of the components in this medication.

As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride ophthalmic solution. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

Since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin Hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin hydrochloride ophthalmic solution is administered to a nursing mother.

Store bellow 25°C. Do not freeze. Store in cool and dry place, protected from light. Keep out of the reach of children. Do not touch dropper tip to any surface as this may contaminate this preparation. Do not use after one month of first opening.

Ophthalmic antibacterial drugs

The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

One drop in the affected eye(s) 2 times daily for 7 days.

In 1-6% patients the most frequently reported ocular adverse events are eye irritation, pyrexia, conjunctivitis, decreased visual acuity, dry eye, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage and tearing.

Prolonged use may result in overgrowth of non-susceptible organisms, including fungi with other anti-infective.

Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride.

Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as there are no adequate and well-documented studies in pregnant women. Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin is administered to a breast feeding mother.

Pediatric Use: The safety and effectiveness of Moxifloxacin in infants below four months of age was not proven. However, several clinical studies show that the drug may be used safely in children even younger than one month of age.

Geriatric Use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.

There is practically no risk of adverse effects due to accidental ingestion, since a bottle of 5 ml eye drops solution contains only 25 mg Moxifloxacin that is much lower than recommended daily oral dose.

Store in a cool and dry place away from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. After one month of the first opening do not use the medicine of dropper.

Adapalene cream or gel is indicated for topical treatment of acne vulgaris.

Topical retinoid and related preparations

Adapalene acts on retinoid receptors that are commonly found in the skin of face, back and chest. Biochemical and pharmacological studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of that represent important features in the pathology of acne vulgaris. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Absorption of Adapalene through human skin is low.

Adapalene 0.1%: It should be applied to the affected areas of skin, once daily at night-time.
Adapalene 0.3%: It should be applied to the entire face and any other affected areas of the skin, once daily in the evening.

Children below 12 years of age: Safety and effectiveness in children below 12 years of age have not been established.

A thin film of gel or cream should be applied to the skin areas where lesions present, using enough to cover the entire affected areas lightly.

Erythema, scaling, dryness, pruritus, burning sensation, skin irritation, stinging unburn, acne flares, etc. are commonly seen during the first month of therapy but usually lessen with continued use of the medication.

Adapalene should not be administered to individuals who are hypersensitive to Adapalene or any of its components.

Adapalene should not be applied to cuts, abrasions, eczematous or sunburned skin.

Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime) should be approached with caution. Exercise particular caution in using preparations containing sulfur, resorcinol or salicylic acid in combination with Adapalene. If any of these preparations have been used, it is advisable not to start therapy with Adapalene until the effects of such preparations in skin have subsided. If combined use of both medications is important, it is better to use in two different times.

Use Adapalene during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in breast milk. Exercise caution when administering Adapalene to a nursing mother.

Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.

Adapalene cream or gel is indicated for topical treatment of acne vulgaris.

Topical retinoid and related preparations

Adapalene acts on retinoid receptors that are commonly found in the skin of face, back and chest. Biochemical and pharmacological studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of that represent important features in the pathology of acne vulgaris. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Absorption of Adapalene through human skin is low.

Adapalene 0.1%: It should be applied to the affected areas of skin, once daily at night-time.
Adapalene 0.3%: It should be applied to the entire face and any other affected areas of the skin, once daily in the evening.

Children below 12 years of age: Safety and effectiveness in children below 12 years of age have not been established.

A thin film of gel or cream should be applied to the skin areas where lesions present, using enough to cover the entire affected areas lightly.

Erythema, scaling, dryness, pruritus, burning sensation, skin irritation, stinging unburn, acne flares, etc. are commonly seen during the first month of therapy but usually lessen with continued use of the medication.

Adapalene should not be administered to individuals who are hypersensitive to Adapalene or any of its components.

Adapalene should not be applied to cuts, abrasions, eczematous or sunburned skin.

Concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime) should be approached with caution. Exercise particular caution in using preparations containing sulfur, resorcinol or salicylic acid in combination with Adapalene. If any of these preparations have been used, it is advisable not to start therapy with Adapalene until the effects of such preparations in skin have subsided. If combined use of both medications is important, it is better to use in two different times.

Use Adapalene during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in breast milk. Exercise caution when administering Adapalene to a nursing mother.

Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.

Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Topical retinoid and related preparations

Adapalene & Benzoyl peroxide gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene binds to specific retinoic acid nuclear receptors but does not bind to cytosolic receptor protein. Biochemical and pharmacological profile studies have demonstrated that Adapalene is a modulator of cellular differentiation, keratinization and inflammatory processes. Adapalene binds with specific retinoic acid nuclear receptors that normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects.

Apply a thin film of Adapalene & Benzoyl peroxide gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Adapalene & Benzoyl peroxide is not for oral, ophthalmic, or intravaginal use.

Pediatric use: The safety and effectiveness of Adapalene and Benzoyl peroxide gel in pediatric patients under the age of 12 years have not been established.

Erythema, scaling, dryness, and stinging/ burning may occur. Most commonly reported adverse events are dry skin, contact dermatitis, application site burning, application site irritation, and skin irritation.

Should not be administered to individuals who are hypersensitive to any of its component.

Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.

Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. No formal drug-drug interaction studies were conducted.

There are no well-controlled trials in pregnant women treated with Adapalene and Benzoyl peroxide. Animal reproduction studies have not been conducted with the combination gel or Benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, this preparation should be used during pregnancy only if the potential benefit justifies the risk to the fetus. It is not known whether Adapalene or Benzoyl peroxide is excreted in human milk following use. Caution should be exercised when administered to a nursing woman.

Store in a cool (below 25°C) and dry place protected from light and moisture. Keep out of the reach of children. Keep the tube tightly closed after use.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Fexofenadine Hydrochloride is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria.

Non-sedating antihistamines

Fexofenadine Hydrochloride is an antihistamine with selective peripheral H1-receptor antagonist activity. It is rapidly absorbed after oral administration and peak plasma concentration is reached in 2-3 hours. It does not appear to cross the blood brain barrier.

Seasonal Allergic Rhinitis-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 2 to 11 years

• Suspension: 30 mg or 5 ml twice daily
• In case of impaired renal function: 30 mg or 5 ml once daily

Chronic Idiopathic Urticaria-

Adults and children 12 years and older:

• Tablet: 60 mg twice daily or 120 mg once daily or 180 mg once daily 
• In case of impaired renal function: 60 mg once daily

Children from 6 to 11 years:

• Tablet: 30 mg twice daily or 60 mg once daily
• In case of impaired renal function: 30 mg once daily

Children from 6 months to less than 2 years:

• Suspension: 15 mg or 2.5 ml (1/2 tsp) twice daily
• In case of impaired renal function: 15 mg or 2.5 ml (1/2 tsp) once daily

Children from 2 to 11 years:

• Suspension: 30 mg or 5 ml (1 tsp) twice daily
• In case of impaired renal function: 30 mg or 5 ml (1 tsp) once daily

Common side effects are headache, fatigue, drowsiness, nausea, dry mouth and gastrointestinal disturbances.

Contraindicated in patients with known hypersensitivity to Fexofenadine Hydrochloride or any of its ingredients.

Caution should be exercised in elderly patient and patient with decreased renal function.

Plasma concentration of Fexofenadine Hydrochloride have been increased when given with erythromycin or ketoconazole. Aluminium and magnesium hydroxide containing antacid reduces the absorption of Fexofenadine Hydrochloride.

US FDA pregnancy category of Fexofenadine Hydrochloride is C. So, Fexofenadine Hydrochloride should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

In case of an overdose, standard measures to remove any unabsorbed drug should be employed. Symptomatic and supportive treatment is recommended. There has been no reported case of an acute overdose of Fexofenadine hydrochloride.

Keep in a dry place away from light and heat. Keep out of the reach of children.